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临床试验/NCT04032730
NCT04032730已完成不适用

Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study (PRospective Study of Adherence in M/XDR-TB Implementation Science) Aim 2

Centre for the AIDS Programme of Research in South Africa1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2018年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
171
试验地点
1
主要终点
TB treatment outcomes

研究概览

简要总结

The goal of the proposed study is to enhance adherence and retention in care for M/XDR-TB HIV patients through enhanced standard of care, targeted transition to outpatient medication self-administration prior to hospital discharge, and use of community adherence groups, with an overarching goal of promoting patient engagement in a care continuum.

详细描述

Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people living with HIV (1). Globally, the incidence of multidrug-resistant tuberculosis (MDR-TB) and extensively drug resistant tuberculosis (XDR-TB), the most drug-resistant forms of TB, has approximately doubled over the past fifteen years (1-3). Nowhere has this increased incidence generated more concern than in South Africa where interactions between TB and generalized HIV epidemics are causing 'explosive' TB incidence (4-6) and case-fatality are threatening to undermine the progress reached with antiretroviral therapy (ART) (7, 8).

Medication adherence, a key predictor of outcomes in M/XDR-TB and HIV treatment, is understudied in high burden TB-HIV settings (9-11). Patient losses during transitions in the care continuum are frequent (12), increase mortality and limit control of the linked epidemics. Demands of M/XDR-TB HIV treatment are severe including extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern medicine (13-15).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • MTB culture positive with at least isoniazid and rifampicin resistance OR Molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin OR Polymerase chain reaction test (Xpert MTB/RIF) result showing MTB positive and RIF resistance. OR MTB positive with Rifampicin monoresistance
  • Initiating treatment for M/XDR-TB which includes Bedaquiline (BDQ) or Moxifloxacin/Levaquin
  • Have capacity for informed consent
  • HIV Positive Patients: on ART or initiating ART within the following 4 weeks as per clinician recommendation

排除标准

  • Discretion of IOR or clinician

结局指标

主要结局

TB treatment outcomes

时间窗: 9-24 months

The number of participants with TB treatment outcomes as assessed by death or culture conversion.

Adherence in M/XDR-TB HIV outcomes

时间窗: 9-24 months

The number of participants that are adherent to their TB and ARV medication as assessed by: * the use of wisepill device (electronic pill box). 2 wisepill devices are provided to participants in the intervention arm, one for their ART medication and one for their TB medication (namely Bedaquiline). * By self reporting via 7-day recall and 30-day recall * By self reporting via Visual analogue scale

Retention in care

时间窗: 9-24 months

Retention in care will be assessed by loss to follow-up.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Principal Investigator
主要研究者

Dr Nesri Padayatchi

Deputy Director

Centre for the AIDS Programme of Research in South Africa

研究点 (1)

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